After snaring the U.S. FDA’s approval for the Evoque tricuspid valve device, Edwards Lifesciences Corp. petitioned the Centers for Medicare & Medicaid Services for a national coverage determination for transcatheter tricuspid valve replacement devices.
Continuous glucose monitors continue to post positive results for managing diabetes in an ever-expanding population. Long a mainstay of disease management for those with type 1 diabetes, the devices have also proved themselves in treating type 2 diabetes that requires multiple daily injections of insulin.
All eyes were on Tandem Diabetes Care Inc.’s presentation of the tiny Mobi pump at a standing-room-only event during the American Diabetes Association’s 84th Scientific Sessions in Orlando. In addition to showcasing the 18 ways the device can be worn, Tandem highlighted results from its user survey which found that 86% of respondents reported that the device improved their quality of life.
Dexcom Inc. and Insulet Corp. both reported introductions of their products into new countries on the eve of the 2024 American Diabetes Association annual meeting in Orlando, Fla. The two firms also announced the U.S. launch of Insulet’s Omnipod 5 tubeless automated insulin delivery system with connectivity to Dexcom’s G7, the company’s latest generation continuous glucose monitor.
As new treatment options are being continually investigated and trialed against Parkinson’s disease, the possibilities offered by deep brain stimulation (DBS) risk being overlooked. Though not a cure, the therapy could vastly improve the quality of life for patients with the disease.
The granting of emergency use authorization by the U.S. FDA to Roche AG for its four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and respiratory syncytial virus will allow the company to quickly bring the test to near-patient care environments ahead of the flu season, to address a real need in the marketplace, Ian Parfrement, head of the point of care customer area, at Roche Diagnostics, told BioWorld.
Abbott Laboratories received U.S. FDA clearance for its Lingo and Libre Rio over-the-counter continuous glucose monitoring systems, enabling it to challenge Dexcom Inc. in this rapidly growing market. Dexcom received FDA clearance for its OTC Stela continuous glucose monitor in March.
The U.S FDA approved Camaps FX for use in pregnant women with type 1 diabetes. This first, hybrid, closed-loop app was developed by Camdiab Ltd., a spinout from Cambridge University, allows individuals aged two years and older with type 1 diabetes to manage their glucose levels.
News out of the Heart Rhythm Society 2024 meeting May 16-19 highlighted the rapid disruption pulsed field ablation (PFA) devices have wrought in cardiac arrhythmia treatment, so it is little surprise to see that PFAs are among the top five technologies with transformative potential identified by Clarivate plc in its Medical Technologies to Watch in 2024 report. The impact of the other four – continuous glucose monitors (CGM) for diabetes, neurostimulation devices, surgical robotics and renal denervation – has been just as revolutionary, if longer in being realized.
Boston Scientific Corp. is hoping to help change European guidelines on the use of intravascular imaging during percutaneous coronary intervention procedures, Emile Mehanna, medical affairs and medical education director, interventional cardiology, EMEA, told BioWorld.
